MAUDE Adverse Event Report: STAAR SURGICAL COMPANY IMPLANTABLE COLLAMER LENS (ICL); PHAKIC TORIC INTRAOCULAR LENS

Model Number	VTICM513.2
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/05/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The reporter indicated that a 13.2mm vticm513.2 implantable collamer lens of a -8.5/1.50/070 (sphere/cylinder/axis) lens was damaged.The lens was not implanted.
Additional Manufacturer Narrative
A4-a6:unk h6: work order search: no similar complaints within associated lots were found.(b)(4).
Additional Manufacturer Narrative
H3 - device evaluation: the lens was returned in a microcentrifuge vial with residue/debris on the lens.Visual inspection found the lens haptic torn with foreign material on the lens surface specifically residue on lens optic.Claim #(b)(4).
Additional Manufacturer Narrative
D4 - unique identifier (udi) # corrected to (b)(4).Claim #(b)(4).

• Brand Name: IMPLANTABLE COLLAMER LENS (ICL)
• Common Device Name: PHAKIC TORIC INTRAOCULAR LENS
• Manufacturer (Section D): STAAR SURGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• Manufacturer (Section G): STAAR SUGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• Manufacturer Contact: joselene muniz ; 800 royal oaks dr. suite:210; monrovia, CA 91016 ; 8002927902
• MDR Report Key: 18223267
• Report Number: 2023826-2023-05165
• Device Sequence Number: 20251758
• Product Code: QCB
• UDI-Device Identifier: 00840311311439
• UDI-Public: 00840311311439
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: P030016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2026
• Device Model Number: VTICM513.2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/14/2023
• Supplement Date Received by Manufacturer: 01/19/2024; 03/07/2024
• Initial Report FDA Received Date: 11/28/2023
• Supplement Report FDA Received Date: 01/19/2024; 03/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/23/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CARTRIDGE MODEL: SFC-45 LOT# 1633269.; FOAM TIP PLUNGER - LOT# UNK.; INJECTOR MODEL: MSI-TF - LOT# UNK.
• Patient Sex: Female